FEBRUARY 21, 2024
GLAUKOS CORPORATION (NYSE: GKOS)
FOURTH QUARTER & FULL YEAR 2023 IN REVIEW
Important Information
This document is intended to be read by investors in advance of regularly scheduled quarterly conference calls and was designed to provide a review of Glaukos Corporation's recent financial and operational performance and general business outlook.
Please see "Forward-Looking Statements" and "Statement Regarding Use of Non-GAAP Financial Measures" in the "Additional Information" section of this document.
Conference Call Information
Date: | February 21, 2024 |
Time: | 4:30 p.m. ET / 1:30 p.m. PT |
Dial-in numbers: | 1-888-210-2212 (U.S.), 1-646-960-0390 (International) |
Confirmation ID: | 7935742 |
Live webcast: | Events page at the Glaukos Investor Relations website at |
http://investors.glaukos.comor at thislink. | |
Webcast replay: | A replay of the webcast will be archived on the Glaukos Investor Relations website |
following completion of the call. |
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FEBRUARY 21, 2024
FOURTH QUARTER & FULL YEAR 2023 FINANCIAL RESULTS SUMMARY
Ophthalmic pharmaceutical and medical technology company focused on | ||||||
Business Description | developing and commercializing novel, dropless platform therapies designed | |||||
to disrupt the conventional standard of care and improve outcomes for | ||||||
patients suffering from chronic eye diseases | ||||||
Glaucoma | ||||||
Disease Categories | Corneal Health | |||||
Retinal Disease | ||||||
4Q 2023 | FY 2023 | |||||
Revenue (Growth) | $82.4 million | $314.7 million | ||||
(+16% reported, +15% constant currency | (+11% reported, +12% constant currency | |||||
vs. 4Q 2022) | vs. FY 2022) | |||||
Gross Margin (Non- | 4Q 2023 | FY 2023 | ||||
83.8% | 83.0% | |||||
GAAP) | ||||||
(versus 83.6% in 4Q 2022) | (versus 83.5% in FY 2022) | |||||
Cash & Cash | $301.3 million as of December 31, 2023 (versus $306.7 million as of | |||||
Equivalents, Short- | ||||||
Term Investments, | September 30, 2023) | |||||
and Restricted Cash | ||||||
FY2024 Sales | FY 2024 global consolidated revenues of $350 - $360 million expected | |||||
Guidance | ||||||
See "Statement Regarding Use of Non-GAAP Financial Measures" and the Non-GAAP reconciliations included within the Additional Information section of this document. Reconciliations for each of constant currency revenue growth, Non-GAAP Gross Margin, and the other non-GAAP financial measures disclosed in this document to the most directly comparable GAAP financial measure are provided.
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FEBRUARY 21, 2024
Revenue Performance & Commercial Overview
Global Consolidated Revenue Performance
Glaukos reported record fourth quarter net revenues of $82.4 million that were up 16% on a reported basis or up 15% on a constant currency basis versus 4Q 2022. Our fourth quarter performance reflected continued solid execution across our global Glaucoma and Corneal Health franchises.
For fiscal year 2023, net revenues were approximately $315 million, up 11% on a reported basis, or up 12% on a constant currency basis, compared to net revenues of approximately $283 million in 2022.
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FEBRUARY 21, 2024
Franchise Revenue Performance
U.S. Glaucoma
Our fourth quarter U.S. Glaucoma net revenues were approximately $38.7 million, representing year- over-year growth of 10% versus 4Q 2023.
For fiscal year 2023, U.S. Glaucoma net revenues were approximately $151.5 million, representing year- over-year growth of 5% versus fiscal year 2022.
International Glaucoma
Our fourth quarter International Glaucoma net revenues were approximately $21.9 million, representing year-over-year reported growth of 25%, or 23% on a constant currency basis, versus 4Q 2022. The strong growth internationally during the fourth quarter was broad-based as we continue to scale our international infrastructure and increasingly drive MIGS forward as the standard of care in each region and every major market in the world.
For fiscal year 2023, International Glaucoma net revenues were approximately $85.6 million, representing year-over-year reported growth of 23%, or 24% on a constant currency basis, versus fiscal year 2022.
Corneal Health
Our record fourth quarter Corneal Health net revenues were approximately $21.8 million, representing year-over-year growth of 19% versus 4Q 2022, including U.S. Photrexa® record sales of $19.2 million, which increased 26% year-over-year as our key strategic initiatives continue to take hold in support of this important business.
For fiscal year 2023, Corneal Health net revenues were approximately $77.7 million, representing year- over-year reported growth of 13% versus fiscal year 2022. U.S Photrexa sales in 2023 were $66.3 million, an increase of 18% compared to 2022.
We continue to focus on expanding access for keratoconus patients suffering from this rare disease.
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FEBRUARY 21, 2024
2024 Revenue Guidance Reaffirmed
Glaukos reaffirms full-year 2024 global consolidated net sales of $350 - $360 million. This guidance attempts to take into consideration:
- Potential growing contributions from iStent infinite®
- Potential growing contributions from iDose® TR, which are expected to be modest in the first half of 2024 and more back-end weighted in the latter part of 2024 into 2025
- Potential ordering pattern volatility within our U.S. Glaucoma franchise during the first half of 2024 due to uncertainty associated with MAC LCDs
- The continued estimated impact on U.S. Glaucoma volumes related to professional fee reimbursement for combination-cataract trabecular bypass surgery versus other more invasive alternatives
- The latest foreign currency exchange spot rates as of our 4Q23 earnings call on February 21, 2024
- Combo-cataractMIGS competition globally
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FEBRUARY 21, 2024
Research & Development / Pipeline Overview
Pipeline Summary
Our five key dropless technology therapy platforms designed to disrupt traditional treatment paradigms and generate cascades of future innovation are as follows:
- iStent® micro-scale surgical devices
- iDose® sustained-release procedural pharmaceuticals
- iLution™ transdermal pharmaceuticals
- iLink® bio-activated pharmaceuticals
- Retina XR bio-erodiblesustained-release pharmaceuticals
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FEBRUARY 21, 2024
Key R&D and Pipeline Updates
We are continuing to prudently invest in and advance our fulsome pipeline of core novel platforms, supported by more than $500 million of investment into our R&D programs since 2018 alone. Recent updates in our pipeline include:
- Announced FDA approval of iDose TR (4Q 2023)
- Commenced initial commercial launch activites for iDose TR (1Q 2024)
- Commenced PMA pivotal trial for iStent infinite in mild-to-moderate glaucoma patients (4Q 2023)
- Commenced first-in-humanRetina XR clinical development program for IVT multi-kinase inhibitor in wet AMD patients (GLK-401) (4Q 2023)
- Commenced Phase 2a clinical trial for iLution™ Travoprost (4Q 2023)
- Progressing towards trial completion in second Phase 3 confirmatory pivotal trial for Epioxa™ (Epi- on)
- Phase 3 confirmatory trial results together with already-completed first Phase 3 trial expected to support targeted NDA submission for Epioxa by the end of 2024
- Advancing patient enrollment in two Phase 2 trials for third-generationiLink therapy
- PRESERFLO MicroShunt
- U.S. Investigation Device Excemption (IDE) application open - targeting clinical study commencement in 1H 2024
- Ongoing regulatory submissions and approvals in Latin America
- Preparing to commence Phase 3 clincial trial for iDose TREX, our next-generationiDose therapy, by the end of 2024
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FEBRUARY 21, 2024
Product / Pipeline Chart
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FEBRUARY 21, 2024
Other Financial Performance Overview
As a reminder, we discuss our financial performance on a non-GAAP basis and summarize our GAAP performance. We encourage investors to review our GAAP to non-GAAP reconciliation which can be found in our earnings press release, the Additional Information section contained herein, as well as the Investor Relations section of our website.
Fourth quarter 2023 financial performance summary:
Gross | 4Q 2023: 84% | • Please note that our non-GAAP adjustments to cost of |
4Q 2022: 84% | goods sold include substantial amounts related to | |
Margin | ||
YoY ∆: +20 bps | Avedro acquisition accounting | |
(Non-GAAP) | ||
4Q 2023: $62.3M | • 16% sequential increase vs $53.5M in 3Q 2023 | |
SG&A | 4Q 2022: $51.1M | • YoY and QoQ increases primarily reflect various one- |
(Non-GAAP) | YoY ∆: +22% | time expenses in the quarter, including non-cash stock |
comp associated with certain performance award | ||
target achievements, samples expense, and | ||
commercial and G&A investments globally and new | ||
product launch activities | ||
4Q 2023: $37.1M | • 11% sequential increase vs $33.3M in 3Q 2023 | |
R&D | 4Q 2022: $35.8M | • YoY and QoQ increases reflect continued investment in |
(Non-GAAP) | YoY ∆: +3% | and advancement of R&D programs |
SG&A + | 4Q 2023: $99.4M | • 14% sequential increase vs $86.8M in 3Q 2023 |
4Q 2022: $87.0M | ||
R&D | ||
YoY ∆: +14% | ||
(Non-GAAP) | ||
Op Loss (Non-GAAP) | ||
Earnings | 4Q 2023: ($32.4M) | |
4Q 2022: ($27.4M) | ||
Net Loss (Non-GAAP) | ||
4Q 2023: ($30.6M) | ||
4Q 2022: ($25.1M) | ||
Diluted EPS (Non-GAAP) | ||
4Q 2023: ($0.63) | ||
4Q 2022: ($0.53) | ||
4Q 2023: $4.2M | • Capital expenditures moderating to levels more | |
CapEx | 4Q 2022: 8.2M | consistent with historical norms, a trend expected to |
YoY ∆: (-$4.0M) | continue throughout 2024 | |
• YoY decrease reflects the substantial completion of | ||
Aliso Viejo, CA and Burlington, MA facilities | ||
4Q 2023: $301.3M | • Operating expenses and capital investments | |
Cash | 3Q 2023: $306.7M | |
QoQ ∆: (-$5.4M) | ||
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FEBRUARY 21, 2024
Annual Supplement
Provided annually in conjunction with the fourth quarter earnings call
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Disclaimer
Glaukos Corporation published this content on 21 February 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 March 2024 09:59:05 UTC.